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Patients Still Filing Lawsuits Against DePuy for ASR Metallosis

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In early 2012, a joint investigation by the BBC and the British Medical Journal found that toxic ions from metal-on-metal hip implants, like the DePuy ASR device, can seep into the surrounding tissues, leaving some patients with long-term disabilities.

Though the ASR was recalled in 2010, patients continue to come forward reporting problems with the implant. A DePuy hip lawyer representing a man implanted with the DePuy ASR recently filed a lawsuit in California, claiming that his client was seriously injured by metal poisoning, which caused his implant to detach and disconnect.

Metal-on-Metal Implants Can Cause Problems

The FDA approved the DePuy ASR in 2005. The device places a metal cup inside a metal socket, and during normal wear and tear, the components may rub against one another, depositing tiny shards of cobalt and chromium into the surrounding tissues of the joint.

Over time, these shards can cause inflammation, swelling, pseudotumors, and even tissue death and bone loss. The changes in the joint can lead to the loosening of the components, causing pain, difficulty walking, and eventual implant failure. If the metal ions get into the bloodstream, they can cause systemic illness that may include headaches, dizziness, ringing in the ears, limb weakness, and other health issues.

Device Approved Without Clinical Trials

In May 2011, the FDA required the makers of all-metal implants to conduct additional studies to further determine their safety profiles. Many DePuy lawyers and injured patients have criticized the FDA for failing to require DePuy Orthopaedics to conduct more thorough studies on the implant in the first place—before it was approved.

DePuy was able to gain expedited approval through the fast-track 510(k) system, which required only that they prove the device significantly similar to one already on the market. By doing so, the company skirted the expense and time that would have been required for clinical studies.

Company Delays Recall

Long before the 2010 DePuy hip recall, patients had reported problems with the product. Adverse events submitted to the FDA described incidences of pain, popping sounds, fractures, dead tissue, pseudotumors, metallosis, and implant dislocation. The agency received over 400 complaints since 2008, while patients and medical doctors in Australia and the U.K. were asking questions as early as 2007.

Yet between 2008 and 2010, DePuy continued to assert that the ASR was safe. In March 2010, however, they sent a field safety notice to doctors, acknowledging the higher than normal rate of complications. Later, in August, they implemented the DePuy ASR recall, withdrawing the product from the market. It was then that they admitted the device had a failure rate of 13 percent. A later report from the British Hip Society and the British Orthopaedic Association revealed a 21 percent failure rate after four years, and a 49 percent failure rate after six years.

The plaintiff in the California lawsuit brings counts of liability, breach of warranties, and fraudulent concealment. He claims the company misrepresented the risks to the public, and believes they should be held liable for his injuries. Three similar cases previously filed in Nevada were reported to have recently settled out of court for about $200,000 each.